Suboxone, the DEA and Opioid REMS

In June I told you about the FDA developing “Risk Evaluation and Mitigation Strategies” (REMS) to put tighter controls on the use of opioid medications. (See URGENT: FDA May Remove or Limit Access to Opioid Pain Medications) One of the strategies being considered is requiring doctors to have special education and certification in order to prescribe each type of opioid medication.

One medication that is already being treated this way is Suboxone. Suboxone is a combination of buprenorphine and naloxone and is used to treat opioid dependence and/or addiction. Buprenorphine is an opiod medication similar to other opioids such as morphine, however, it produces less euphoric effects. Naloxone blocks the effects of opioids – although when taken under the tongue as directed, it does not affect the action of the buprenorphine.

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Currently, physicians who want to prescribe Suboxone are required to receive special training in how to administer it. This training usually consists of a one-day course after which the doctor is authorized by the DEA to prescribe Suboxone. This all sounds reasonable. What could possibly be wrong with physicians being trained to properly prescribe a new medication?

What is wrong is that now the DEA apparently feels free to intimidate and harass these doctors. Recently the DEA sent a letter to many of the authorized physicians notifying them that the agency was developing plans to inspect their medical practice. The letter told them if they wanted to discontinue prescribing the drug, all they had to do was fill out the enclosed form. However, if they chose to continue prescribing Suboxone, they were to fill out a questionnaire and prepare for an inspection.

No one knows yet how many physicians will decide to opt out and stop prescribing Suboxone because it's just not worth putting up with the DEA's intrusion into their practices. But it would be hard to fault them for doing so.

What's even more scary is that Suboxone is a medication designed to help people break a dependence on or addiction to other opioids. If the DEA is so intrusive with Suboxone, how much worse will they be with other opioids under REMS initiatives? There are already a lot of doctors who refuse to prescribe any kind of opioid medications because of fear of the DEA. How many more will join their ranks if the restrictions are tightened even further?

Physicians who are doing their best to help their patients should not have to fear being second quessed, and possibly even prosecuted, for it. Doctors who spend their time and money to receive special training that will benefit their patients should be thanked and encouraged, not threatened and discouraged.

Although the government may not fully appreciate them, I do. I want to take this opportunity to thank each and every doctor who cares enough and is courageous enough put quality care of their patients first. We need you and appreciate you.